First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases

Table 1 Data overview of first- and second-line treatment with over-the-scope clips in patients with upper and lower non-variceal gastrointestinal bleeding (2009-2016)

Ref.	n	Primary success (%)	Patients/clinical		Follow up, mean (mo)	Rebleeding, n	UGIB/LGIB, n	Design
			success (n/%)
			FLET	SLET
Wedi et al[4], 2016	44	85.4	31/?	13/?	-	6	41/3	Single center
								Retro
Manno et al[3], 2015	40	100	40/100	-	1	-	40/0	Single center
								Retro
Manta et al[5], 2013	30	97	-	93.3	1	2	23/7	Multicenter
								Retro
Kirschniak et al[6], 2011	27	100	27/92.6	-	0.13	2	12/15	Single center
								Retro
Skinner et al[7], 2014	12	100	12/83.4	-	1	2	12	Single center
								Retro
Chan et al[8], 2013	9	100	3/100	6/77.7	2	2	9	Single center
								Pro
Nishiyma et al[9], 2013	9	77.8	9/77.7	-	2.2	2	8/1	Single center
								Retro
Baron et al[10], 2012	7	100	-	7/100	1	0	6/1	Multicenter
								Retro
Albert et al[11], 2011	7	100	-	7/57	1	3	6/1	Single center
								Pro
Repici et al[12], 2009	7	100	3/100	4/100	3	0	3/4	Single center
								Retro
Mönkemüller et al[13], 2014	6	100	-	6/100	10	0	6	Multicenter
								Retro
Alcaide et al[14], 2014	2	100	-	2/100	-	-	1/1	Single center
								Retro
Jayaraman et al[15], 2013	2	100	2/100	-	2.9	0	0/2	Single center
								Retro
Sulz et al[16], 2014	1	100	1/100	-	-	0	1	Single center
								Pro

Retro: Retrospective; Pro: Prospective.

Table 2 Type of bleeding lesions in the upper and lower gastrointestinal tracts, n

Lesions	FIa	FIb	FIIa	FIIb	Spurting	Oozing	Total	FLET	SLET
UGIB							(n = 69)	(n = 39)	(n = 33)
Ulcer
Cardiac	4	1	3				8	5	3
Gastric	2	8		1			11	7	4
Duodenal	8	11	7				26	17	9
Jejunal		3					3	2	1
Polypectomy
Gastric						3	3	3
Duodenal				2			2		2
Anastomoses					2	3	5	1	4
Gastrojejunal
Mallory-Weiss						2	2	2
Vascular Malformation						1	1		1
Heart device
Dieulafoy					4		4	2	2
Metastasis
Gastric						4	4		4
Lesions	FIa	FIb	FIIa	FIIb	Spurting	Oozing	Total	FLET	SLET
LGIB							(n = 31)	(n = 22)	(n = 9)
Ulcer
Rectal	6	3	2	1			12	9	3
Cecal	1	1					2	2
Polypectomy
Rectal					2		2		2
Colonal					1	3	4	4
Anastomoses
Ileocolonic				1	2	1	4	3	1
Hemorrhoidal					2	1	3	2	1
Diverticular						3	3	1	2
Tumor
Colonic			1				1	1

UGIB: Upper gastrointestinal bleeding; LGIB: Lower gastrointestinal bleeding; FLET: First-line endoscopic treatment; SLET: Second-line endoscopic treatment.

Table 3 Demographics and characteristics n (%)

	Total (n = 93)	UGI (n = 63)	LGI (n = 30)	P value
Sex, male	58 (62)	38 (60)	20 (67)	0.361
Age (yr), median (IQR)	72 (19-98)	68 (27-92)	74 (19-93)	0.580
Complete Rockall score, median (IQR)	-	7 (3-10)	-	-
Anticoagulation	46 (50)	29 (46)	17 (56)	0.231
In-Hospital-Mortality	20 (22)	17 (27)	3 (10)	0.051
Lesions and clips	(n = 100)	(n = 69)	(n = 31)
Bleeding source
Ulcers	66	50 (72)	16 (52)	0.018
Other	34	19 (27)	15 (48)
Active bleeding1	82	56 (81)	26 (84)	0.492
First-line-therapy	61	39 (57)	22 (71)	0.125
Primary failure (including technical failure n = 2)	12	8 (12)	4 (13)	0.545
Rebleeding
complete	16 (16)	11 (16)	5 (16)	0.597

¹Forrest classification of ulcers Ia/Ib and spurting/oozing bleeding lesions. IQR: Interquartile range; UGI: Upper gastrointestinal tract; LGI: Lower gastrointestinal tract.

Table 4 Complete Rockall risk score of patients with upper gastrointestinal bleeding

Rockall risk score	1	2	3	4	5	6	7	8+	Total
n	0	0	1	0	6	13	13	30	63

Table 5 Comparison of total mortality, rebleeding-associated mortality and rebleeding events between upper gastrointestinal bleeding patients who received best standard of care (original Rockall group) and those who underwent first-line or second-line endoscopic treatment over-the-scope clips (Freiburg group)

Total mortality Rockall < 7	Total mortality Rockall≥7
Rockall1 5.8% vs Freiburg2 10%; P = 0.327	Rockall 32.8% vs Freiburg 34.8%; P = 0.865
145 of 2499 vs 2 of 20	150 of 457 vs 15 of 43
Rebleeding-associated mortality	Rebleeding-associated mortality
Rockall < 7	Rockall ≥ 7
Rockall 2.8% vs Freiburg 5%; P = 0.436	Rockall 22.3% vs Freiburg 13.9%; P = 0.247
70 of 2499 vs 1 of 20	102 of 355 vs 6 of 43
Rebleeding events Rockall < 7	Rebleeding events Rockall ≥ 7
Rockall 13.8% vs Freiburg 15%; P = 0.750	Rockall 46.8% vs Freiburg 18.6%; P = 0.0003
345 of 2499 vs 3 of 20	214 of 457 vs 8 of 43

¹Best standard of care;

²OTSC FLET and SLET. OTSC: Over-the-scope clips; FLET: First-line endoscopic treatment; SLET: Second-line endoscopic treatment.

Table 6 Univariate and multivariate analyses of predictors of rebleeding after over-the-scope clips placement

Predictor	Univariate analysis		Multivariate analysis
	OR (CI)	P value	OR (CI)	P value
Bleeding (active/non active)	0.94 (0.24-3.72)	0.586	1.43 (0.33-6.21)	0.636
Localization (UGIB/LGIB)	0.99 (0.31-3.13)	0.597	1.67 (0.45-6.15)	0.451
Anticoagulation (Y/N)	1.41 (0.48-4.15)	0.359	1.34 (0.43-4.20)	0.611
Lesion (ulcers/others)	1.65 (0.53-5.17)	0.282	2.03 (0.56-7.27)	0.275
Treatment (SLET/FLET)	4.40 (1.39-13.90)	0.009	5.29 (1.53-18.24)	0.008

UGIB: Upper gastrointestinal bleeding; LGIB: Lower gastrointestinal bleeding; FLET: First-line endoscopic treatment; SLET: Second-line endoscopic treatment.